Abstract: Background and Objective: The aqueous infusion of Aerva javanica (AJ) has been reported to possess several pharmacological properties as antivenom and anti-inflammatory, being widely distributed its use in phytotherapy has increased, however, its safety profile remains unknown. The main purpose of this study is the identification of bioactive compounds to assess the acute and subacute oral toxicity of Aerva javanica gender in mice and rats. Materials and Methods: The phytochemical screening was carried out using standard colorimetric methods. In LD50 assays, the oral doses (500, 750, 1000, 2500 and 5000 mg kg1 b.wt.) of tested plant extract was administered to mice. In subacute toxicity, 250 and 500 mg kg1 b.wt., were tested on rats and changes in weight, biochemical, haematological and histopathological parameters were studied. The data obtained were determined using one-way analysis of variance (ANOVA) and post hoc Tukey test. Results: Present findings highlight the difference of bioactive component levels between male and female plants, no death was recorded at acute toxicity assessment, the plant is considered as non-toxic at a single dose, the LD50 value was above 5000 mg kg1. Subacute treatment did not significantly alter animal weight growth, organ to body weight ratios, biochemical parameters or any damage of internal organs. The hemoglobin (HB), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC) and platelet levels significantly decreased in the female rats submitted to 500 mg kg1 b.wt., of the female plant extract. Conclusion: The dioecy could have a real impact on the chemical composition of plant genders and their medicinal effects. The AJ aqueous extracts does not cause acute toxicity but in subacute toxicity the female (AJ) cause a hypochromic anemia on female rats. However, further toxicological assays would be necessary to confirm the safety of this plant extract.